An unblinded randomized study of influenza A/H1N1 2009 (swine flu)resistance under standard and extended duration Oseltamivir treatment
- Conditions
- influenza A/H1N1 2009Infection - Other infectious diseases
- Registration Number
- ACTRN12610000361000
- Lead Sponsor
- Roche Products NZ Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 125
1. Male and non-pregnant female subjects age greater than or equal to 5 years:
2. A positive Influenza A Rapid Antigen Test (RAT) performed on an adequate nasopharyngeal specimen, in accordance with the manufacturer’s instructions. If the RAT is negative but, in the investigator’s opinion, there is strong clinical suspicion of any type of influenza then the subject may be enrolled.
3. Presence of fever at the time of screening of greater or equal to 37.8 degrees celius (greater or equal to 100.04 degrees F) taken orally. A subject self-report of a history of a fever or feverishness within the 24 hours prior to screening will also qualify for enrolment in the absence of documented fever at the time of screening.
4. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms).
5. Onset of symptoms no more than 48 hours before presentation for screening.
6. Female of non-childbearing potential, either surgically sterilised or at least one year post-menopausal. If a female is of childbearing potential, she must be abstinent or using adequate contraceptive precautions, including but not limited to the following: barrier methods (condom or diaphragm), intrauterine contraceptive device (IUCD), oral contraceptive, or equivalent hormonal contraceptive (e.g. progesterone-only implant, cutaneous hormonal patch, injectable contraceptives) and agree to continue such precautions for the duration of the study.
7. Written informed consent.
1. Women who are pregnant or breast-feeding.
2. Presence of clinically significant signs of acute respiratory distress
3. History of severe chronic obstructive pulmonary disease (COPD).
4. History of heart failure of angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
5. History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50mL/min).
6. Clinical evidence of worsening of any chronic medical condition (temporarily associated with the onset of symptoms of influenza) which, in the investigator’s opinion, indicated that such finding(s) could represent complications of influenza.
7. Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics.
8. Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with >10 mg prednisone or equivalent on a daily basis within 30 days of screening.
9. Currently receiving treatment for viral hepatitis B or viral hepatitis C.
10. Presence of known Human immunodeficiency virus (HIV).
11. History of alcohol abuse or drug addiction within 1 year prior to admission in the study.
12. Current participation in a study of any investigational drug.
13. Any other medical condition which, in the opinion of the investigator, would preclude safe participation in the clinical trial.
14. Known hypersensitivity to Oseltamivir.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in the proportion of patients shedding virus with each duration and the proportion which exhibit resistance. Nasopharyngeal swabs will be obtained from both nostrils. The specimens will be analyzed for influenza viruses by polymerase chain reaction (PCR) methods within 48 hrs.[9 days (window +1 days) post screening/randomisation visit which is day 0]
- Secondary Outcome Measures
Name Time Method Differences in reduction of viral load, measured at days 5 and 10, in subjects given standard and extended duration oseltamivir. For subjects that are PCR positive, phenotypic viral sensitivity to oseltamivir will be determined by means of the NA Star neuraminidase chemilumiscent assay. In instances where resistance is detected, sequencing of the viral genome will be undertaken to identify the relevant resistance mutations.[At 5 days and 9 days (window +1 days) screening/randomisation visit which is day 0]